​Participants will gain a thorough understanding of:

• Best practices used to implement quality processes that ...

• Address risks and opportunities, and thus ...

• Lead to the improvement of the QMS performance.

 

Who Should Attend

 

• Those involved in QMS implementation, operation, and maintenance

• QMS auditors, who wish to fully understand the QMS implementation process  

• Senior managers involved in, and/ or affected by, the outcome of QMS audits

• Expert advisors in Quality Management Systems 

• Technical experts wanting to prepare for a quality function or for a QMS project management

       function

• Those considering QMS certification to the ISO 9001 standard.

 

Learning Objectives

 

On completion of this course, delegates will be able to:

• Understand the implementation of a QMS, in accordance with the requirements of ISO 9001

• Understand the concepts, principles, methods and techniques required for effective QMS management

• Identify the risks and opportunities associated with an organization 

• Understand the relationship between the components of a QMS and compliance with the requirements of

      different stakeholders

• Support an organization in implementing, managing and maintaining a QMS as specified in ISO 9001and

      ISO 9004

• Manage a team implementing an ISO 9001-compliant QMS

• Advise the senior management of an organization on best practices in managing product or service quality

• Analyse data and information and make the right decisions within the context of quality management 

• Prepare an organization for an ISO 9001 certification audit.

 

Course Agenda and Content

 

Day 1: Introduction to Quality Management Systems, ISO 9001, and Initiation of the QMS Project

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• Course objectives and structure

• Management Systems (MS) and Management System Standards (MSS)

• ISO MSS and the High-Level Structure (HLS - Annex SL)

• Quality Management Systems (QMS)

• The ISO 9000 family (series) of standards

• ISO 9001: 2015 Context of the Organisation, Risk-based Thinking, and Leadership Requirements

• QMS requirements: clauses 4 to 10 of ISO 9001

• Understanding the organization and clarifying the quality objectives.

 

Day 2: Planning and Development of an ISO 9001-compliant QMS

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• Project management approach and stages

• Analysis of the existing management system 

• Leadership and approval of the QMS project 

• Project initiation for QMS development and implementation

• QMS scope

• QMS documentation structure

• Mandatory documents of an ISO 9001-compliant QMS

• Definition of the document management process

• Quality management policies

• Risk assessment

• Planning of product and service provision

• Definition of the QMS organizational structure

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Day 3: Implementation of the QMS

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• Operations Management 

• Training and awareness planning

• Communications planning

• Product and service requirements, design, and purchasing process

• Product and service realization and control.

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Day 4: QMS Measurement, Continuous Improvement and Preparation for the Certification Audit

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• Monitoring, measurement, analysis and evaluation of the QMS effectiveness

• Internal audit

• Management review

• Treatment of issues and non-conformities

• Continual improvement 

• Preparing for the certification audit

• The QMS certification audit stages, registration process, and certification life-cycle

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Day 5: Certification Exam.

 

Prerequisites

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The following are general prerequisites for attending our training courses:

• Proficiency in the English language

• Consideration for other course participants

• Willingness to actively participate during the training sessions, and an open mind

      to learn new ways of working.

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Completion of the ISO 9001 Foundation training is required to attend this course.

 

Training Approach

 

The course covers both theory and practice:

• Slide-based training sessions, illustrated with examples

• Business cases

• Preparation for the Foundation exam

• Practice test (mock exam) similar to the certification exam.

 

Examination

 

• Duration: 90 min

• Format: closed book, 60 multiple-choice questions

• Pass mark: 70% (42 correct answers)

 

Competence domains based on the requirements of ISO 9001:

• Fundamental principles and concepts in Quality Management

• ISO 9001 requirements for QMS

• Planning, developing, and implementing a QMS

• Monitoring, measuring, and evaluating QMS performance

• Continual improvement of QMS

• Preparing for the certification audit.

 

Certification

 

The ISO 9001 Lead Implementer certificate will be issued to delegates passing the exam.

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General Course Information

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For general course information please click on the link here.

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N.B. Please read our Terms & Conditions (T&Cs) and ask for clarifications, if any, before booking your training event.

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Book now to reserve an on-site or online instructor-led training event of your choice for your company's delegates.

 

For more details about our:

• List of training courses please click here.

• Consulting services please click here

• Workshops please click here.

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For queries, including non-obligation quotes, please contact us.

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